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Intractable diarrhoea and severe weight loss by roflumilast

Identifier

012795

Type of spiritual experience

Hallucination

Background

Why didn't they find out what was causing the bronchitis?

"Roflumilast (trade names Daxas, Daliresp) is a drug that acts as a selective, long-acting inhibitor of the enzyme PDE-4. It is believed to have anti-inflammatory effects and is under development as an orally administered drug for the treatment of inflammatory conditions of the lungs such as asthma and chronic obstructive pulmonary disease (COPD).  In June 2010, Daxas was approved in the EU for severe COPD associated with chronic bronchitis. In March 2011, Daliresp gained FDA approval in the US for reducing COPD exacerbations"

A description of the experience

Med Clin (Barc). 2013 Aug 4;141(3):116-8. doi: 10.1016/j.medcli.2013.04.028. Epub 2013 Jun 12.

[Intractable diarrhoea and severe weight loss by roflumilast].

[Article in Spanish]

Horna O1, Toyas C.  1Servicio de Farmacia, Hospital Royo Villanova, Zaragoza, España. ohorna@salud.aragon.es

Abstract

BACKGROUND AND OBJECTIVE:  Roflumilast is a recently marketed drug, indicated for maintenance treatment of severe chronic obstructive pulmonary disease associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.

MATERIAL AND METHODS:  The safety data of this drug have always been subjected to controversy and concerns. The Food and Drug Administration rejected the drug after the first evaluation, asking the company to clarify the adverse reactions during the investigation process, the European Medicines Agency approved the drug including a Risk Management Plan, designed to promote a safe use of the drug.

RESULTS:  During the first months after the marketing process, the Spanish Pharmacovigilance System has already been acquainted of several adverse events notifications; therefore, these patients may be closely monitored, mainly because of digestive and psychiatric disorders.

CONCLUSIONS:  Here we report the case of a female patient who showed a serious digestive clinical profile and a severe weight loss, more than 25% of her initial weight, when a treatment with roflumilast was started. The suspicion of a side effect as the cause of the reported clinical profile and its resolution required 3 hospital admissions.

Copyright © 2013 Elsevier España, S.L. All rights reserved.

KEYWORDS:

Chronic obstructive pulmonary disease; Diarrea; Diarrhoea; Enfermedad pulmonar obstructiva crónica; Pérdida de peso; Reacción adversa; Roflumilast; Side effect; Weight loss

PMID:  23768858

The source of the experience

PubMed

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